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PLYMOUTH, Minn.--(BUSINESS WIRE)--Interrad Medical, Inc., a privately held medical device company, announces excellent results of a clinical study published in JAMA Pediatrics titled, “Securement to prevent non-cuffed central venous catheter dislodgement in pediatrics The SECURED superiority randomized clinical trial,” Kleidon, et al..
明尼苏达州普利茅斯——(商业新闻短讯)——私人医疗器械公司Interrad Medical,Inc.宣布了一项发表在《美国医学会儿科杂志》(JAMA Pediatrics)上的临床研究的优秀结果,该研究题为“防止儿科无套囊中心静脉导管移位的固定安全优势随机临床试验”,Kleidon等人。。
This multi-center, randomized controlled trial was undertaken in partnership with The Queensland Children’s Hospital, The University of Queensland, and researchers of the globally respected Alliance for Vascular Access Teaching and Research (AVATAR), Griffith University, Brisbane, Australia. The primary purpose was to compare the dislodgement rate (partial or complete) of non-cuffed CVCs secured with SecurAcath to the market-leading adhesive securement device.
这项多中心随机对照试验是与昆士兰儿童医院,昆士兰大学以及全球知名的血管通路教学与研究联盟(AVATAR),澳大利亚布里斯班格里菲斯大学的研究人员合作进行的。主要目的是比较用SecurAcath固定的非套囊CVC与市场领先的粘合剂固定装置的移位率(部分或完全)。
307 pediatric patients were randomized, 153 to SecurAcath and 154 to the adhesive device..
307名儿科患者被随机分配,153名接受了SecurAcath治疗,154名接受了粘合剂治疗。。
The results showed an impressive 4.4-fold decreased catheter dislodgement in the SecurAcath group (5.2%) compared to adhesive device group (22.7%).
结果显示,与粘合剂组(22.7%)相比,SecurAcath组(5.2%)的导管移位减少了4.4倍。
Seven secondary outcomes also highly favored SecurAcath as well. Chief among these, complications reported during catheter dwell were 39% lower for SecurAcath most notably, central line associated bloodstream infections (CLABSI) which were 50% lower in the SecurAcath group.
七个次要结果也非常有利于SecurAcath。其中,导管停留期间报告的并发症比SecurAcath低39%,最值得注意的是,SecurAcath组的中心线相关血流感染(CLABSI)低50%。
The study’s comparative cost savings analysis showed that overall, the SecurAcath device saved AU$36.60 (US$24.54) with every use.
该研究的比较成本节约分析显示,总体而言,SecurAcath设备每次使用可节省36.60澳元(24.54美元)。
“Catheter dislodgement is a major clinical problem for our pediatric patients, with potentially life-threatening consequences. The results of this study clearly show SecurAcath reduces dislodgement and saves money, therefore, SecurAcath should be used preferentially over adhesive device securement,” said Tricia Kleidon, RN, MNursePrac, lead author of the study publication..
“导管移位是我们儿科患者的一个主要临床问题,可能会危及生命。这项研究的结果清楚地表明,SecurAcath可以减少移位并节省资金,因此,SecurAcath应该优先使用,而不是粘合剂固定,”该研究出版物的主要作者、MNursePrac的注册护士特里西亚·克莱登说。。
“We are extremely pleased with the very favorable results of this important comparative study,” said Joe Goldberger, President and CEO of Interrad Medical, Inc. “This superiority evidence provides the strongest support to date that SecurAcath will become the new global standard for catheter securement.”.
Interrad Medical,Inc.总裁兼首席执行官乔·戈德伯格(JoeGoldberger)说:“我们对这项重要的比较研究的非常有利的结果感到非常高兴。这一优越性证据为SecurAcath将成为导管固定的新全球标准提供了最有力的支持。”。
SecurAcath is the only subcutaneous catheter securement device in the world. Just one SecurAcath lasts the life of the line and can significantly reduce the risk of catheter-related infections, dramatically decrease catheter dislodgement and migration, and decrease catheter replacement costs resulting in significant cost savings.
SecurAcath是世界上唯一的皮下导管固定装置。只有一个SecurAcath可以持续使用寿命,并且可以显着降低导管相关感染的风险,显着减少导管移位和迁移,并降低导管更换成本,从而显着节省成本。
SecurAcath has overwhelmingly more positive clinical evidence and independent clinical guidance than any other catheter securement device in the world with 27 peer-reviewed scientific publications consistently concluding clinical and economic benefits. Learn more at securacath.com.
与世界上任何其他导管固定装置相比,SecurAcath具有绝大多数积极的临床证据和独立的临床指导,27篇同行评审的科学出版物一致总结了临床和经济效益。请访问securacath.com了解更多信息。
About Interrad Medical, Inc.
关于Interrad Medical,Inc。
Plymouth, Minnesota-based Interrad Medical, Inc. is a developer, manufacturer and marketer of medical devices designed for minimally-invasive medical procedures. The lead product, the SecurAcath Subcutaneous Anchor Securement System (SASS), is a revolutionary new method for catheter securement that does not require sutures or adhesives..
总部位于明尼苏达州普利茅斯的Interrad Medical,Inc.是一家为微创医疗程序设计的医疗设备的开发、制造商和销售商。主导产品SecurAcath皮下锚固定系统(SASS)是一种革命性的导管固定新方法,不需要缝合线或粘合剂。。
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements..
本新闻稿中包含的任何不描述历史事实的声明可能构成前瞻性声明。本文中包含的任何前瞻性陈述均基于我们管理层当前的信念和期望,但会受到许多风险、不确定性和环境变化的影响,这可能导致实际结果或公司行为与这些陈述中明示或暗示的内容产生重大差异。。